Weekly Digest – April 2026 Weekly Digest – April 2026 13 April 2026: Ifinatamab Deruxtecan receives U.S. Priority Review for previously treated extensive-stage SCLC progressing after platinum-based chemotherapy Daiichi Sankyo and Merck have received U.S. FDA acceptance and Priority Review […]
Weekly Digest – April 2026 Weekly Digest – April 2026 14 April 2026: GlycoNex receives PMDA approval in Japan to initiate first-in-human phase 1 trial of GNX1021 in gastrointestinal cancers GlycoNex, Inc. has received approval from Japan’s Pharmaceuticals and Medical […]
Weekly Digest – April 2026 Weekly Digest – April 2026 15 April 2026: CSPC Pharmaceutical Group Limited obtains NMPA clinical trial approval for TF-targeted ADC SYS6051 in China CSPC Pharmaceutical Group Limited has received clinical trial approval in China for […]
Weekly Digest – April 2026 Weekly Digest – April 2026 09 April 2026: The New Drug Application (NDA) for DB-1303/BNT323 for unresectable or metastatic HER2-positive adult breast cancer has been accepted by the NMPA DualityBio’s HER2 ADC DB-1303 (BNT323 / […]
Weekly Digest – April 2026 Weekly Digest – April 2026 07 April 2026: NextCure receives Fast Track Designation for SIM0505 (CDH6 ADC) in ovarian cancer NextCure has received FDA Fast Track Designation for its ADC SIM0505 for the treatment of […]
Weekly Digest – April 2026 Weekly Digest – April 2026 09 April 2026: Celltrion ADC drug candidate CT-P71 receives FDA Fast Track Designation for urothelial carcinoma Celltrion’s ADC candidate CT-P71 has received FDA Fast Track Designation for the treatment of […]
Weekly Digest – April 2026 Weekly Digest – April 2026 07 April 2026: Corbus Pharmaceuticals announces broad alignment with FDA on registration path for CRB-701 in second-line HNSCC and cervical cancer Corbus Pharmaceuticals has achieved broad alignment with the FDA […]
Weekly Digest – April 2026 Weekly Digest – April 2026 30 March 2026: Aktis Oncology announces FDA clearance of Investigational New Drug applications for AKY-2519 Aktis Oncology’s radiopharmaceutical candidate AKY-2519 has received IND clearance from the U.S. FDA, enabling the […]
Weekly Digest – March 2026 Weekly Digest – March 2026 23 March 2026: GSK’s B7-H3-targeted ADC, Risvutatug rezetecan, granted Orphan Drug Designation for small-cell lung cancer in Japan GSK’s investigational B7-H3-targeted ADC, risvutatug rezetecan (Ris-Rez), has received ODD in Japan […]
Weekly Digest – March 2026 Weekly Digest – March 2026 13 March 2026: Alphamab Oncology announces IND application for innovative EGFR/HER3 dual payload bispecific ADC JSKN021 was officially accepted by CDE Alphamab Oncology has achieved a key regulatory milestone, as […]
